July 11, 2002 - Possession of a Select Agent

The American Society for Microbiology (ASM) is writing in response to the request for comments on the Department of Health and Human Service's Centers for Disease Control and Prevention Proposed Data Collections Submitted for Public Comment and Recommendations published in the Federal Register: July 2, 2002 (Volume 67, Number 127)] [Notices]

The ASM is the largest life science society with over 40,000 members and its principal goal is the promotion of scientific knowledge of microbiology for the benefit of human welfare. The ASM has worked with the Administration, the Congress and federal agencies on measures to protect against biological weapons and bioterrorism. ASM members are involved in research and public health initiatives aimed at eradicating the scourge of infectious diseases. The ASM worked with the CDC in the promulgation of the 1997 Select Agent Transfer regulations. As such, the ASM is uniquely positioned to comment on the proposed notification regulations proposed to meet the requirements of the Public Health Security and Bioterrorism Preparedness Act of 2002 (Public Law 107-188).

The ASM has supported the passage of legislation and the implementation of appropriate regulations to require the registration of facilities possessing select agents that pose special threats for use in bioterrorism. The ASM clearly sees the practical importance of developing a secure national data base of the locations of select agents and thus supports the requirement that CDC and the Department of Agriculture be notified of those possessing such agents. This is a requirement Section 202(a) of the Public Health Security and Bioterrorism Preparedness Act of 2002.

The ASM is aware of the Select Agent Interagency Work Group and hopes that the following comments will be considered and that the issues raised in this letter will be adequately addressed by the Select Agent Work Group. The ASM wishes to be of assistance to the Select Agent Work Group and offers the full range of expertise in the microbiological sciences which is uniquely found in the ASM membership. The July 2 Federal Register notice is incomplete and ambiguous, which makes it impossible to judge the reasonableness of the proposed notification procedure or the regulatory burden. The Federal Register notice provides no information about what will be required to complete the Application for Notice of Possession of a select agent. Without such information, it is difficult to estimate accurately the time, cost, or other aspects of the regulatory burden. Additionally, no list of select agents was provided in the Federal Register notice. Therefore, the universe of select agents requiring notification is not defined in the notice. Clearly, the list of biological agents and toxins will be different from the current list of select agents in Appendix A of 42 CFR Part 72 because the Federal Register notice indicates that agricultural biological agents that are deemed a threat to animal health or animal products will be listed. Because the scope of the list is unknown, the regulatory burden and impact on the scientific research and diagnostic communities is unclear.

The absence of a definition of a facility is a particular concern. The Federal Register notice states that facilities, rather than individuals, who possess a select agent shall notify CDC by completing the Application for Notice of Possession of a Select Agent. However, the Federal Register notice does not adequately define a "facility." The Federal Register notice states that a facility should be considered as a single geographic site, such as a building or complex of building at a single mailing address. The description provides no restriction to facilities that possess or are reasonably anticipated to possess biological agents and could be interpreted to include any office or building in the definition of a facility.

The absence of a definition of a facility might not be an issue if only facilities possessing listed agents were required to file the Application for Notice of Possession of a Select Agent. In those circumstances, we would presume that the term "facilities" would be similar to the definition at 42 CFR § 72.6(j). However, the Federal Register Notice says that facilities not possessing select agents must also file the Application for Notice of Possession of a Select Agent stating that the facility does not possess such agents. Facilities that do not possess a listed biological agent or toxin are required to complete the declaration of non-possession and submit the form. If the CDC/HHS requires reports by facilities not possessing select agents, it should provide a different and more complete definition of "facility" than exists in the current proposal. Otherwise, it is unclear what the universe of facilities that must file applications for notification of possession or nonpossession of select agents will be. This appears unreasonable and not the intent of the Public Health Security and Bioterrorism Preparedness Act of 2002 (Public Law 107-188). We recommend that CDC clarify which facilities must file the Application for Notice of Possession of a Select Agents and that the definition be appropriate.

We note that Section 202(a) of the Public Health Security and Bioterrorism Preparedness Response Act of 2002 requires that "persons (unless exempt under subsection (g) of section 351A of the Public Health Service Act….) in possession of biological agents or toxins listed under section 351A of the Public Health Service Act shall notify the Secretary of HHS of such possession."Therefore, it appears the proposed requirement for completing and filing an application by every facility exceeds the scope of Section 202 even if the definition of facility is narrowed to a well defined set of facilities possessing biological agents.For purposes of this comment, however, our principal point is that the term facilities must be defined in a manner consistent with achieving the regulatory objectives of the notice process. Even with this restriction it is unclear how the CDC will notify those facilities that must file such applications. The universe that must learn of the requirement to file applications of notification is not defined and without a massive educational outreach program there is no possibility that the necessary information and applications will reach the affected community in time to respond by September 10, 2002.

Issues may also arise from the requirement that the responsible facility official (RFO) who completes the notification not be an individual who actually possesses, uses, or transfers such agents or toxins. In some small biotech companies, diagnostic labs, veterinarian offices, etc. there may only be one individual who can complete the notification form and that individual may be the one in possession of the select agents. HHS/CDC must take into account the nature of facilities that could be in possession of select agents. Perhaps because the universe of facilities has not been defined, the CDC appears to have misestimated the number of facilities that would have to file applications for notification of possessions of select agents. Even taking into account the most serious agricultural biothreat agents, most estimates are that well under 1,000 facilities in the U.S. are in possession of select agents. The Federal Register notice indicates that the number may be 100 times higher. It also estimates that just under 100,000 facilities will have to notify that they are not in possession of listed agents. Given that there are 150,000 diagnostic laboratories in the U.S., 2,500 universities and colleges, hundreds of biotechnology companies, and numerous veterinarian and agricultural facilities-most of which do not possess select agents, the estimate of those that would have to file for non-possession under the proposed notification process appears to be grossly underestimated.

Also the assumption is that an inventory at a facility not possessing a select agent is trivial and not time consuming. If a facility has many cultures, conducting an inventory to determine that no select agent is present is just as time consuming as doing an inventory when such agents are present.Filing notification when select agents are present may be more burdensome depending upon the information that is required.This may be especially true to meet the requirement to supply information when available that would aid in identification of the source of an agent. However, without the details of the filing requirements the regulatory burden cannot be determined.

Thus, the ASM concludes that more precise information must be given to judge the reasonableness of the proposed notification process.The ASM appreciates the opportunity to comment and would be pleased to provide additional comments and recommendations to assist the CDC and HHS in any way possible as new regulations are developed for select agents.